ofatumumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
human origin	4951	679818-59-8

Description:

Molecule	Description
Synonyms: ofatumumab arzerra GSK1841157 HuMax-CD20 2F2	Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ofatumumab
arzerra
GSK1841157
HuMax-CD20
2F2

Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company
March 23, 2021	PMDA	Novartis Pharma K.K.
April 19, 2010	EMA	Novartis Europharm Ltd
Oct. 26, 2009	FDA	GLAXO GRP LTD

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	159.41	25.42	88	2876	97579	50504581
Pyrexia	123.63	25.42	130	2834	380073	50222087
Chills	122.65	25.42	74	2890	96613	50505547
Influenza like illness	67.63	25.42	42	2922	57417	50544743
Progressive multifocal leukoencephalopathy	59.05	25.42	23	2941	11434	50590726
Accidental exposure to product	55.34	25.42	27	2937	23030	50579130
Headache	52.03	25.42	100	2864	506435	50095725
Multiple sclerosis relapse	39.69	25.42	27	2937	42937	50559223
Pneumonia	36.62	25.42	73	2891	378328	50223832
Neutropenic sepsis	35.23	25.42	17	2947	14130	50588030
COVID-19	28.79	25.42	23	2941	46639	50555521
Fatigue	27.46	25.42	97	2867	707504	49894656
Hemianopia	27.42	25.42	7	2957	875	50601285

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	197.84	30.62	131	2994	112109	29459293
Pneumonia	148.01	30.62	174	2951	319998	29251404
Neutropenic sepsis	107.48	30.62	42	3083	11685	29559717
Pyrexia	100.01	30.62	136	2989	287486	29283916
Second primary malignancy	50.95	30.62	21	3104	6684	29564718
Infusion related reaction	48.88	30.62	39	3086	43847	29527555
Disease progression	48.40	30.62	51	3074	81865	29489537
Tumour lysis syndrome	41.84	30.62	23	3102	13861	29557541
Neutropenia	39.02	30.62	58	3067	131653	29439749
Chills	37.89	30.62	42	3083	71258	29500144
Injection related reaction	36.45	30.62	7	3118	127	29571275
Hypercalcaemia	32.67	30.62	19	3106	12740	29558662

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	260.82	23.70	165	4573	187492	64306502
Pneumonia	203.99	23.70	226	4512	559350	63934644
Pyrexia	175.30	23.70	209	4529	558435	63935559
Neutropenic sepsis	124.14	23.70	51	4687	23221	64470773
Chills	102.61	23.70	83	4655	137181	64356813
Progressive multifocal leukoencephalopathy	74.19	23.70	33	4705	18199	64475795
Influenza like illness	70.01	23.70	48	4690	61654	64432340
Second primary malignancy	65.62	23.70	27	4711	12310	64481684
Disease progression	48.87	23.70	56	4682	141624	64352370
Tumour lysis syndrome	48.05	23.70	25	4713	19415	64474579
Neutropenia	41.77	23.70	68	4670	239556	64254438
Infusion related reaction	36.15	23.70	52	4686	164415	64329579
Injection related reaction	32.82	23.70	8	4730	659	64493335
Squamous cell carcinoma of skin	31.44	23.70	16	4722	11860	64482134
Hepatitis B	31.43	23.70	14	4724	7731	64486263
Basal cell carcinoma	25.86	23.70	20	4718	30818	64463176
Sepsis	25.73	23.70	54	4684	230287	64263707
Infection	25.05	23.70	47	4691	184833	64309161
COVID-19	24.56	23.70	27	4711	65113	64428881
Blood immunoglobulin A decreased	24.42	23.70	6	4732	511	64493483
Lower respiratory tract infection	23.88	23.70	32	4706	94582	64399412

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FA02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES CD20 (Clusters of Differentiation 20) inhibitors
ATC	L04AA52	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA MoA	N0000175078	CD20-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents
FDA EPC	N0000175657	CD20-directed Cytolytic Antibody

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Chronic lymphoid leukemia, disease	indication	92814006
Relapsing multiple sclerosis	indication	230372003
Secondary progressive multiple sclerosis	indication	425500002	DOID:0050783

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
B-lymphocyte antigen CD20	Surface antigen	P11836	CD20_HUMAN	ANTIBODY BINDING	Kd	9.92		IUPHAR	DRUG LABEL

External reference:

ID	Source
D09314	KEGG_DRUG
4029460	VUID
N0000180305	NUI
4029460	VANDF
CHEMBL1201836	ChEMBL_ID
C527517	MESH_SUPPLEMENTAL_RECORD_UI
6778	IUPHAR_LIGAND_ID
8606	INN_ID
DB06650	DRUGBANK_ID
M95KG522R0	UNII
8254	PUBCHEM_CID
712566	RXNORM
168892	MMSL
26825	MMSL
d07509	MMSL
444607009	SNOMEDCT_US
444609007	SNOMEDCT_US
895672000	SNOMEDCT_US
C1832027	UMLSCUI
013301	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0669	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0690	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
KESIMPTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1007	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	30 sections
KESIMPTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1007	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	30 sections